Assessment of Right Ventricular Volume in Tetralogy of Fallott (TOF) Patients

Completed

• Conditions: Tetralogy of Fallot
• Interventions: Device: VentriPoint Medical System

• Registration Number: NCT01419756
• Lead Sponsor: VentriPoint Diagnostics Ltd.

Brief Summary

Assessment of Right Ventricular Volume using the VentriPoint Medical system in patients with Tetralogy of Fallot following repair; a comparison study to cMRI.

The objective of this study is: To evaluate the accuracy of the VentriPoint Medical System to calculate right ventricular volumes in patients with Tetralogy of Fallot following surgical repair.

Secondary objectives are: To validate Inter and Intra observer variability at 3 clinical sites.

The analyses will be the same for EDV and ESV. For either right ventricular volume, the primary effectiveness measure is the % difference between VMS and cMRI results, i.e. (VMS-cMRI)\*100%/average of VMS and cMRI results. There will be two null hypotheses for the primary analysis:

H0+: true mean % difference \> 10% and H0-: true mean % difference \< -10%

The observed mean % difference will be presented with 95% confidence intervals. The VMS right ventricular volume estimates will be regarded as equivalent to cMRI estimates if both H0+ and H0- are rejected at a 1-sided 0.025 level by a paired t test for both EDV and ESV. Since H0+ and H0- cannot both be true, the total type I error rate for each measure is 0.025 and the overall type I error rate for both EDV and ESV is 0.05.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Last Update Submitted: 2014-10-03
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Patients with Tetralogy of Fallot following surgical repair
• Patients who can be expected to lie motionless during imaging

Exclusion Criteria

• Lack of informed consent
• Surgical repair for Tetralogy of Fallot with RV-PA conduit
• Known arrhythmia that interferes with image acquisition.
• Implanted cardiac defibrillator, pacemaker, or other devices containing ferromagnetic materials
• Pregnant woman
• Contraindications for MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Arm	VentriPoint Medical System	Imaging comparison study. No intervention.

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is the percent difference between the VentriPoint Medical System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular volumes (EDV and ESV) in subjects following repair for TOF.	4 months	The trial will be regarded as successful if it demonstrates the mean VMS-cMRI percent difference to be \<10% and \>-10% at a 1-sided 0.025 statistical significance level for each of EDV and ESV, with no safety concerns for the VMS procedure.

Trial Locations

Locations (6)

The Children's Hosptial of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States